Clinical trial · Interventional
Povidone-iodine and the Normal Saline Cleaning the Incision for the SSIs
Comparison the Influence of the Povidone-iodine or the Normal Saline Cleaning the Incision for the Incidence of the Surgical Site Infections for Gastric Cancer Patients With Gastrectomy- Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Surgical site infections (SSIs) is one of the most common complications of upper abdominal surgery. Previous studies found that type of surgical incision, emergency operation or not, surgical duration, age of patient, body mass index, malignance duration, malnutrition, complications (diabetes, shock, anemia et al) and drug (Long-term use of corticosteroids) are closely associated with the incidence of SSIs. The general incidence rate of SSIs was about 5% to 40%, although using the preoperative skin disinfectant and other methods to prevent and reduce the SSIs. And for the gastrointestinal surgery, due to the potential risk of infection, SSIs is an important problem which cannot be ignored. On the other hand, gastric cancer is one of the most common digestive system tumors, and gastrectomy is the primary therapeutic options. Therefore, it is important to compare the whether the different liquid (1% povidone-iodine solution or the 0.9% normal saline) wash the incision can influent the incidence of the SSIs.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dehiscence of Laparotomy Wound | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Surgical Site Infections | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Group A (povidone-iodine wash the surgical incision) | Procedure | — | UNRESOLVED |
| Group B (normal saline wash the surgical incision) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A (povidone-iodine group)
- description
- The surgical incision is washed by the mixed solution with 400ml 9% normal saline and 100ml 5% povidone-iodine solution. We declare that we have no conflicts of interest.
- interventionNames
- Procedure: Group A (povidone-iodine wash the surgical incision)
- type
- EXPERIMENTAL
- label
- Group B (normal saline group)
- description
- The surgical incision is washed by the 500ml 0.9% normal saline. We declare that we have no conflicts of interest.
- interventionNames
- Procedure: Group B (normal saline wash the surgical incision)
Primary outcomes (1)
- measure
- Superficial incisional surgical site infections
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Preoperative endoscopy and biopsy confirmed gastric adenocarcinoma, and predictively feasible of conventional open total gastrectomy or subtotal gastrectomy; 2. Predictively resectable diseases, of preoperative staging JGCA 14th Edition cT1N0M0-T4aN+M0, Ia-IIIc stage 3. Age:≤75 years, or ≥18 years; 4. Without serious disease and malignance disease; 5. WHO performance score ≤2, ASA score ≤3; 6. No limit to sexual and race; 7. Informed consent required. Exclusion Criteria: 1. Emergence operation, because of obstruction, perforate, acute hemorrhage and et al; 2. Patients with laparoscopic or laparoscopic-assisted gastrectomy 3. Patients with other severe complications cannot tolerate surgery: such as severe heart and lung diseases, heart function below clinical stage 2, uncontrollable hypertension, pulmonary infection, moderate to severe COPD, chronic bronchitis, severe diabetes and / or renal insufficiency, severe hepatitis and / or function below the rank of CHILD B grade, and severe malnutrition, etc; 4. Patients treated with neoadjuvant chemotherapy or radiation therapy which might affect the efficacy observation; 5. Severity mental diseases; 6. Primary lesion cannot be resected in the pattern of transabdominal gastrectomy, but for Whipple's procedure, or with a transthoracic approach surgery; 7. After signature the Clinical trial agreement, patients and their agent will quit the trial.
References
Publications (0)
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